Subtalar Spacer System

FDA UDI

Class II (US FDA UDI)

by Wright Medical Technology, Inc.

Identity

Trade Name: SUBTALAR SPACER SYSTEM FDA UDI
Generic Name: Subtalar implant, non-bioabsorbable FDA UDI
Model / Reference: 03-009 FDA UDI

Identifiers

Catalog Number: 03-009 FDA UDI
Primary DI / UDI-DI: 00840420169495 FDA UDI
FDA Product Code: HWC FDA UDI
GMDN Term: Subtalar implant, non-bioabsorbable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3040 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

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Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Subtalar implant, non-bioabsorbable

The Subtalar Spacer System is a non-bioabsorbable device designed to stabilize the subtalar/talotarsal joint in patients with hyperpronated feet or heel/arch abnormalities, such as flat foot. Made from a metal alloy or polyethylene, this implant is typically used for up to 10 years.

Similar devices

Also classified as Subtalar implant, non-bioabsorbable.

HORIZON HYBRID SUBTALAR 12MM — BIOPRO, INC. · Class II
HORIZON SUBTALAR GEN 2 10MM — BIOPRO, INC. · Class II
Subtalar MBA Implant System — Smith & Nephew, Inc. · Class II
LSI Arthroereisis Peg — FUSION ORTHOPEDICS, LLC · Class II
HyProCure II Sinus Tarsi Stent Size 06 — Gramedica · Class II
HORIZON TITANIUM SUBTALAR 12MM — BIOPRO, INC. · Class II
HORIZON TITANIUM SUBTALAR 6MM — BIOPRO, INC. · Class II
bioBLOCK® Subtalar Implant System — Ascension Orthopedics, Inc. · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Wright Medical Technology, Inc.

Sources (1)

FDA UDI ff54b06d-09a4-4b90-9ecf-998cf4fea3a1 35 fields · synced Jul 10, 2026